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Cenerimod for Systemic Lupus Erythematosus (OPUS-1 Trial)

Phase 3
Recruiting
Research Sponsored by Idorsia Pharmaceuticals Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently treated with specific SLE background medications as detailed
BILAG Grade B in ≥ 2 organ systems or a BILAG Grade A in ≥ 1 organ system
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-dose baseline) to month 12
Awards & highlights

OPUS-1 Trial Summary

This trial will investigate if cenerimod is effective at reducing symptoms of SLE in adult patients with moderate to severe symptoms.

Who is the study for?
Adults with moderate to severe Systemic Lupus Erythematosus (SLE) who have been diagnosed at least 6 months prior and are on stable SLE medications can join. They need a certain level of disease activity and organ involvement, and women must agree to pregnancy tests and use effective contraception. Excluded are those with heart rate issues, certain heart conditions, severe respiratory diseases, liver problems, recent serious cardiovascular events or treatments that could interfere.Check my eligibility
What is being tested?
The trial is testing Cenerimod's effectiveness in reducing SLE symptoms compared to a placebo over 12 months. It will involve around 420 participants split into two groups: one receiving Cenerimod and the other receiving a placebo pill without active medication.See study design
What are the potential side effects?
While specific side effects for Cenerimod aren't listed here, common ones for new oral medicines may include gastrointestinal discomfort, headaches, potential liver impact or allergic reactions. The study aims to assess safety thoroughly.

OPUS-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently on medication for lupus.
Select...
My lupus is affecting at least two organs moderately or one organ severely.
Select...
My lupus is active, with significant skin or joint symptoms.

OPUS-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-dose baseline) to month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (pre-dose baseline) to month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to Month 12 in the modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) score
Secondary outcome measures
Response on Systemic Lupus Erythematosus Responder Index (SRI) at Month 12
Time to first confirmation of a 4-month sustained modified Systemic Lupus Erythematosus Disease Activity Index-2000 (mSLEDAI-2K) response
Time to first confirmation of a 4-month sustained response in mucocutaneous manifestations

Side effects data

From 2017 Phase 1 & 2 trial • 105 Patients • NCT02472795
8%
Lymphocyte count decreased
8%
Tracheobronchitis
8%
Chronic hepatitis
8%
Cough
8%
Blood alkaline phosphatase increased
8%
Tooth extraction
8%
Cataract
8%
Nasopharyngitis
8%
Intraocular pressure increased
8%
Type 2 diabetes mellitus
8%
Periodontitis
8%
Rhinitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cenerimod 4 mg
Cenerimod 0.5 mg
Matching Placebo
Cenerimod 2 mg
Cenerimod 1 mg

OPUS-1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cenerimod 4 mgExperimental Treatment1 Intervention
Participants will receive cenerimod once daily in addition to background SLE therapy.
Group II: Matching placeboPlacebo Group1 Intervention
Participants will receive matching placebo once daily in addition to background SLE therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cenerimod
2015
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Idorsia Pharmaceuticals Ltd.Lead Sponsor
118 Previous Clinical Trials
32,037 Total Patients Enrolled
Clinical TrialsStudy DirectorIdorsia Pharmaceuticals Ltd.
2,198 Previous Clinical Trials
888,159 Total Patients Enrolled

Media Library

Cenerimod 4 mg Clinical Trial Eligibility Overview. Trial Name: NCT05648500 — Phase 3
Systemic Lupus Erythematosus Research Study Groups: Matching placebo, Cenerimod 4 mg
Systemic Lupus Erythematosus Clinical Trial 2023: Cenerimod 4 mg Highlights & Side Effects. Trial Name: NCT05648500 — Phase 3
Cenerimod 4 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05648500 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Cenerimod 4 mg met the requirements of the Food and Drug Administration?

"Cenerimod 4 mg is rated a 3 on our safety scale due to prior clinical evidence substantiating its efficacy, as well as the multiple sources of data that ensure its security."

Answered by AI

Is the elderly population included in this experimental endeavor?

"For this study, the age requirement is between 18 and 75. There are 19 trials currently available for minors and 108 studies targeting elderly patients."

Answered by AI

Is this trial presently recruiting new participants?

"Affirmative. According to the information provided on clinicaltrials.gov, this medical trial is in its recruitment phase with a requirement of 420 participants across two sites. It was first posted on December 13th 2022 and most recently updated on December 22nd 2022."

Answered by AI

To what extent is the trial population engaged in this experiment?

"Affirmative. According to the clinicaltrials.gov database, enrollment for this medical research is ongoing since its initial launch on December 13th 2022 and latest update on December 22nd 2022. 420 participants are requested at two distinct sites."

Answered by AI

What are the criteria for joining this experimental research program?

"This trial seeks to enrol 420 people that have been diagnosed with Libman-Sacks Disease and are aged 18 - 75. To qualify, participants must satisfy the following conditions: a Systemic Lupus Erythematosus (SLE) diagnosis for at least 6 months prior to screening; an elevated modified Systemic Lupus Erythematosus Disease Activity Index-2000 score of more than 6 points including 2 or more musculoskeletal/mucocutaneous manifestations; British Isles Lupus Assessment Group-2004 Grade B in at least two organ systems or one A grade system; Physician's Global Assessment"

Answered by AI

Who else is applying?

What site did they apply to?
DJL Clinical Research, PLLC
Allen Arthritis
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Hoping clinical trials will help develop a cure for lupus and other illnesses.
PatientReceived 1 prior treatment
I am looking to better deal with Lupus. I want less flare up symptoms and hopefully keep my heart healthy for as long as possible.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long does the screening process take? How many visits? And is there compensation for the screening and visits? How many visits are there?
PatientReceived 1 prior treatment
~240 spots leftby Dec 2025